NCT00866645

A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia

A Randomized Blind Parallel Intramuscular Haloperidol-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Intramuscular Levosulpiride in the Treatment of Chinese Patients With Agitation Of Schizophrenia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy and safety of Intramuscular Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of study (72 hours after first dosing) from baseline.

Detailed description

Secondary Outcome Measures: To evaluate the change of Agitation Calmness Evaluation Scale(ACES), Clinical Global Impression(CGI, including CGI-S and CGI-I),PANSS total scores,Brief Psychiatric Rating Scale(BPRS) total scores and every item of PANSS-EC from baseline to the end of study (Time Frame: 72 hours) \[ Designated as safety issue: No \] To evaluate the change of patients' main complain, physical examination, lab and ECG tests, AE、Rating Scale for Extrapyramidal Side Effect(RSESE) and Barnes Akathisia Scale(BAS)from baseline to the end of study (Time Frame: 72 hours) \[ Designated as safety issue: Yes \]

Conditions

• Agitation

Interventions

Type	Name	Description
DRUG	Intramuscular Haloperidol	1ml：5mg/ampoul the recommended dose is 10 mg per day administered. Doses of 10 mg may be administered 5mg bid with an interval longer than 4 hours for 3 days.
DRUG	Intramuscular Levosulpiride	2ml：50mg/ampoul the recommended dose is 100 mg per day administered. Doses of 100 mg may be administered 50mg bid with an interval longer than 4 hours for 3 days.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-03-20
• Last updated: 2010-12-03

Locations

5 sites across 1 country: China